VIPER PRIME 186750445SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705034529950), received between Jul 8, 2022 and Jul 16, 2024 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Migration” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY FOR FRACTURE ON (B)(6) 2023. AFTER THE SURGERY, IT WAS CONFIRMED THAT OF THE EIGHT SCREWS, SEVERAL THAT WERE NOT CEMENTED HAD BACKED OUT, AND ALL WERE TO BE REMOVED. ON (B)(6) 2024, THE REMOVAL SURGERY WAS PERFORMED. IN THE SURGERY AFTER THE REMOVAL, THE SCREW WITH CEMENT INJECTED FOUND TO BE SHORT AND CONFIRMED TO BE BROKEN. IT WAS CONFIRMED THAT A PART OF THE SCREW HAS REMAINED IN THE BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE SURGEON COMMENTED THAT THERE WAS NO RESISTANCE AT THE TIME OF SCREW REMOVAL, SO IT DID NOT FEEL LIKE IT WAS BROKEN AT THE TIME OF REMOVAL. ALSO, HE MENTIONED THAT THE SCREW LEFT BEHIND IN THE BODY APPEARS TO BE ATTACHED TO THE CEMENT, SO HE DOESN'T THINK IT'S AFFECTED. THIS PC IS RELATED TO (B)(4) WHICH REPORTS THE REMOVAL SURGERY CAUSED BY THE SCREW BACKED OUT AFTER THE INITIAL SURGERY. THIS PC REPORTS THE EVENT THAT A PART OF SCREW WHICH SHOULD HAVE BEEN REMOVED WAS LEFT IN THE BODY DUE TO BREAKAGE. THIS REPORT IS FOR ONE (1) VIPER PRIME CFXFN XTB 5X45MM S THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4)

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19757387 ↗
• InjuryJul 15, 2024Migration; Migration

  IT WAS REPORTED THE PATIENT UNDERWENT A SURGERY FOR FRACTURE ON (B)(6) 2023. AFTER THE SURGERY, IT WAS CONFIRMED THAT SEVERAL OF THE EIGHT SCREWS HAD BACKED OUT. ON (B)(6) 2024, THE REMOVAL SURGERY WAS PERFORMED. THE SURGERY WAS COMPLETED WITH NO SURGICAL DELAY. THE PATIENT STATUS/OUTCOME WAS REPORTED AS STABLE. THIS REPORT CAPTURED THE SCREWS THAT BACKED OUT REQUIRING A REVISION PROCEDURE. IT IS RELATED TO (B)(4) WHICH CAPTURED PART OF ONE SCREW REMAINING IN THE PATIENT AFTER THE REMOVAL SURGERY. THIS REPORT IS FOR A VIPER PRIME SCREW. THIS IS REPORT 3 OF 8 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19743063 ↗
• InjuryJul 15, 2024Migration; Migration

  IT WAS REPORTED THE PATIENT UNDERWENT A SURGERY FOR FRACTURE ON (B)(6) 2023. AFTER THE SURGERY, IT WAS CONFIRMED THAT SEVERAL OF THE EIGHT SCREWS HAD BACKED OUT. ON (B)(6) 2024, THE REMOVAL SURGERY WAS PERFORMED. THE SURGERY WAS COMPLETED WITH NO SURGICAL DELAY. THE PATIENT STATUS/OUTCOME WAS REPORTED AS STABLE. THIS REPORT CAPTURED THE SCREWS THAT BACKED OUT REQUIRING A REVISION PROCEDURE. IT IS RELATED TO (B)(4) WHICH CAPTURED PART OF ONE SCREW REMAINING IN THE PATIENT AFTER THE REMOVAL SURGERY. THIS REPORT IS FOR A VIPER PRIME SCREW. THIS IS REPORT 8 OF 8 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19742991 ↗
• InjuryJul 15, 2024Migration; Migration

  IT WAS REPORTED THE PATIENT UNDERWENT A SURGERY FOR FRACTURE ON (B)(6) 2023. AFTER THE SURGERY, IT WAS CONFIRMED THAT SEVERAL OF THE EIGHT SCREWS HAD BACKED OUT. ON (B)(6) 2024, THE REMOVAL SURGERY WAS PERFORMED. THE SURGERY WAS COMPLETED WITH NO SURGICAL DELAY. THE PATIENT STATUS/OUTCOME WAS REPORTED AS STABLE. THIS REPORT CAPTURED THE SCREWS THAT BACKED OUT REQUIRING A REVISION PROCEDURE. IT IS RELATED TO (B)(4) WHICH CAPTURED PART OF ONE SCREW REMAINING IN THE PATIENT AFTER THE REMOVAL SURGERY. THIS REPORT IS FOR A VIPER PRIME SCREW. THIS IS REPORT 6 OF 8 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19742832 ↗
• InjuryJul 15, 2024Migration; Migration

  IT WAS REPORTED THE PATIENT UNDERWENT A SURGERY FOR FRACTURE ON (B)(6) 2023. AFTER THE SURGERY, IT WAS CONFIRMED THAT SEVERAL OF THE EIGHT SCREWS HAD BACKED OUT. ON (B)(6), 2024, THE REMOVAL SURGERY WAS PERFORMED. THE SURGERY WAS COMPLETED WITH NO SURGICAL DELAY. THE PATIENT STATUS/OUTCOME WAS REPORTED AS STABLE. THIS REPORT CAPTURED THE SCREWS THAT BACKED OUT REQUIRING A REVISION PROCEDURE. IT IS RELATED TO (B)(4) WHICH CAPTURED PART OF ONE SCREW REMAINING IN THE PATIENT AFTER THE REMOVAL SURGERY. THIS REPORT IS FOR A VIPER PRIME SCREW. THIS IS REPORT 1 OF 8 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19742263 ↗
• MalfunctionSep 19, 2023Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY (L3-L5) FOR A LUMBAR BURST FRACTURE ON (B)(6) 2023. AFTER TRANSFERRING TO ANOTHER FACILITY, THE PATIENT HAD A FALL. WHEN THE SURGEON CHECKED THE X-RAY, THE SCREW AT L3 WAS FOUND TO BE CUT-OUT. THE SURGEON'S OPINION IS THAT HE/SHE DOES NOT THINK THE EVENT WAS CAUSED BY THE SCREW¿S DEFECT. NO FURTHER INFORMATION IS AVAILABLE. REMARKS: (B)(4) ARE INVOLVED WITH THE SAME EVENT. (B)(4) (SYNTHES SPINE): CEMENT. (B)(4) (DEPUY SPINE): SCREW. THIS REPORT IS FOR ONE (1) VIPER PRIME CFXFN XTB 5X45MM S THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Fall

  MAUDE report 17773691 ↗
• InjuryJul 8, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED ARAB EMIRATES AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS A VIPER PRIME SCREW BROKEN INSIDE THE PATIENT. THE PATIENT DID NOT HAVE ANY COMPLAINTS BUT WANTED THE SCREW REMOVED. UPON EXAMINATION BEFORE THE SURGERY, IT WAS DISCOVERED THAT ONE OF THE SCREWS WAS BROKEN. THIS REPORT INVOLVES ONE (1) VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 5 X 45MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 14959607 ↗